Science Links Japan | The Efficacy and Safety of SCH 29851 (Loratadine), A Long-acting and Selective Histamine H1 Receptor Antagonist, for Chronic Urticaria in A Phase III, Randomized, Double-blind, Multi-Center Comparative Study. Investigation of Superiority of SCH 29851 10mg Once Daily to SCH 29851 1mg Once Daily and of Non-Inferiority of SCH 29851 10mg Once Daily to Ketotifen Fumarate 1mg Twice Daily.

The Efficacy and Safety of SCH 29851 (Loratadine), A Long-acting and Selective Histamine H1 Receptor Antagonist, for Chronic Urticaria in A Phase III, Randomized, Double-blind, Multi-Center Comparative Study. Investigation of Superiority of SCH 29851 10mg Once Daily to SCH 29851 1mg Once Daily and of Non-Inferiority of SCH 29851 10mg Once Daily to Ketotifen Fumarate 1mg Twice Daily.

Accession number;02A0685000

Title;The Efficacy and Safety of SCH 29851 (Loratadine), A Long-acting and Selective Histamine H1 Receptor Antagonist, for Chronic Urticaria in A Phase III, Randomized, Double-blind, Multi-Center Comparative Study. Investigation of Superiority of SCH 29851 10mg Once Daily to SCH 29851 1mg Once Daily and of Non-Inferiority of SCH 29851 10mg Once Daily to Ketotifen Fumarate 1mg Twice Daily.

Author; KAWASHIMA MAKOTO (Tokyojoidai Hifuka) KUKITA ATSUSHI (Univ. of Tokyo) HARADA SHOTARO (Higashi-Nihon Denshin Denwa, Kanto Byoin) NAKAGAWA HIDEMI (Jichiidai Hifuka) TAKIKAWA MASAHIRO (Hamamatsuidai Hifuka) YAMAMOTO SHOSO (Hiroshima Univ., JPN) NAKASHIMA MITSUYOSHI (Hamamatsu Univ. Sch. of Med.)

Journal Title;Journal of Clinical Therapeutics & Medicines

Journal Code:Y0906A

ISSN:0910-8211

VOL.18;NO.7;PAGE.881-905(2002)

Figure&Table&Reference;FIG.5, TBL.15, REF.22

Pub. Country;Japan

Language;Japanese

Abstract;A phase III double-blind comparative study was conducted with SCH 29851 (loratadine), a long-acting and selective histamine H1 receptor antagonist, in chronic urticaria to verify superiority of 10mg loratadine to 1mg loratadine administered once daily and non-inferiority of 10mg loratadine administered once daily to 1mg ketotifen fumarate twice daily. A total of 335 patients were enrolled. Of these patients, 3 patients received no study drug and were excluded from FAS analysis (80 receiving 1mg loratadine, 128 receiving 10mg loratadine, and 124 receiving ketotifen fumarate were evaluated). No imbalance in patient background factors was observed between groups (p>0.15). At the end of one week of treatment, 10mg loratadine was shown to be significantly superior (p=0.001) to 1mg loratadine in global improvement. With 10mg loratadine, 68.8% of patients achieved moderate or better improvement in contrast to 37.5% with 1mg loratadine. In the rates of disappearance and improvement of pruritus and wheals, 10mg loratadine was also significantly superior to 1mg loratadine (p<0.001). Loratadine (10mg) was also verified to be non-inferior to ketotifen. The 95% two-sided confidence interval of the difference in moderate or better improvement rates at the end of one week of treatment was -5.1 to 18.4%, exceeding the -10% margin. The improvement rate with 10mg loratadine was 68.8% while that with ketotifen fumarate was 62.1%. At the end of two weeks (end of treatment), the improvement rate was 80.5% with loratadine and 62.1% with ketotifen fumarate. The 95% two-sided confidence interval of the difference in improvement rates was 7.4 to 29.3%, with the lower limit of the confidence interval exceeding 0%, indicating that 10mg loratadine was superior to ketotifen fumarate.... (author abst.)

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